FDA posts a draft guidance on patient engagement in medical device clinical trials.
FDA posts a draft guidance for industry on recommendations for changing medically important animal antimicrobial drugs from over-the-counter to prescr...
Bipartisan House members introduce the Creating Hope Reauthorization Act to make permanent a priority review voucher program for pediatric rare diseas...
CDRH seeks comments on a just-released Health of Women Program Strategic Plan that aims to explore the unique issues related to the performance of med...
FDA makes available a final guidance entitled Wholesale Distributor Verification Requirement for Saleable Returned Drug Product Compliance Policy.
FDA Review posts the Federal Register notices for the week ending 9/20/2019.
FDA Review posts product approval summaries for the week ending 9/20/2019.
Darmerica recalls two lots of quinacrine dihydrochloride bulk active pharmaceutical ingredient due to a label mix-up.